RECRUITING

A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy

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Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT).

Official Title

A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma, Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC)

Quick Facts

Study Start:2023-12-14
Study Completion:2030-05-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06129864

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 130 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically or cytologically documented locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, oral cavity, or larynx with no evidence of metastatic disease (i.e. M0).
  2. * Confirmed unresected Stage III, Stage IVA or IVB according to the eighth edition of the American Joint Committee on Cancer (AJCC) staging manual (tumor, node, metastasis (TNM) staging system).
  3. * Participants will have completed definitive concurrent chemoradiotherapy (cCRT) with curative intent within 12 weeks prior to randomization.
  1. * Histologically/cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including participants with squamous cell carcinoma of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland). Participants with \>1 primary tumors are not eligible for the study.
  2. * Participants with any of the following:
  3. 1. Residual disease that needs further treatment with curative intent after definitive cCRT administration;
  4. 2. LA-HNSCC that was resected before definitive cCRT
  5. 3. LA-HNSCC that was treated and is recurrent at the time of screening
  6. * Participants who have received radiotherapy (RT) alone as definitive local therapy for LA-HNSCC.
  7. * Receipt of the last dose of anticancer therapy (chemotherapy and/or RT) \> 12 weeks (84 days) prior to randomization.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Principal Investigator

Robert Haddad, MD
STUDY_CHAIR
Dana Farber Cancer Institute Massachusetts, USA
Lisa Licitra, MD
STUDY_CHAIR
Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan Milan, Italy

Study Locations (Sites)

Research Site
Birmingham, Alabama, 35233
United States
Research Site
Prescott Valley, Arizona, 86314
United States
Research Site
Springdale, Arkansas, 72762
United States
Research Site
Los Angeles, California, 90024
United States
Research Site
Orange, California, 92868
United States
Research Site
San Francisco, California, 94143
United States
Research Site
Santa Rosa, California, 95403
United States
Research Site
Aurora, Colorado, 80045
United States
Research Site
Lone Tree, Colorado, 80124
United States
Research Site
Fort Myers, Florida, 33901
United States
Research Site
Gainesville, Florida, 32610
United States
Research Site
Miami, Florida, 33125
United States
Research Site
Palm Bay, Florida, 32909
United States
Research Site
West Palm Beach, Florida, 33401
United States
Research Site
Niles, Illinois, 60714
United States
Research Site
Des Moines, Iowa, 50309
United States
Research Site
Kansas City, Kansas, 66160
United States
Research Site
Louisville, Kentucky, 40202
United States
Research Site
Baton Rouge, Louisiana, 70817
United States
Research Site
Shreveport, Louisiana, 71101
United States
Research Site
Baltimore, Maryland, 21231
United States
Research Site
Hyattsville, Maryland, 20782
United States
Research Site
Towson, Maryland, 21204
United States
Research Site
Upper Marlboro, Maryland, 20774
United States
Research Site
Boston, Massachusetts, 02215
United States
Research Site
Ann Arbor, Michigan, 48105
United States
Research Site
Ann Arbor, Michigan, 48109
United States
Research Site
Minneapolis, Minnesota, 55417
United States
Research Site
Columbia, Missouri, 65211
United States
Research Site
Saint Louis, Missouri, 63110
United States
Research Site
Saint Louis, Missouri, 63110
United States
Research Site
East Brunswick, New Jersey, 08816
United States
Research Site
Hackensack, New Jersey, 07601
United States
Research Site
New Brunswick, New Jersey, 08901
United States
Research Site
Albuquerque, New Mexico, 87108
United States
Research Site
New York, New York, 10065
United States
Research Site
New York, New York, 10075
United States
Research Site
Stony Brook, New York, 11794
United States
Research Site
Charlotte, North Carolina, 28204
United States
Research Site
Winston-Salem, North Carolina, 27157
United States
Research Site
Cleveland, Ohio, 44106
United States
Research Site
Portland, Oregon, 97213
United States
Research Site
Portland, Oregon, 97239
United States
Research Site
Philadelphia, Pennsylvania, 19107
United States
Research Site
Pittsburgh, Pennsylvania, 15261
United States
Research Site
York, Pennsylvania, 17403
United States
Research Site
Sioux Falls, South Dakota, 57105
United States
Research Site
Nashville, Tennessee, 37212
United States
Research Site
Austin, Texas, 78745
United States
Research Site
Dallas, Texas, 75251
United States
Research Site
Flower Mound, Texas, 75028
United States
Research Site
Houston, Texas, 77030
United States
Research Site
Odessa, Texas, 79761
United States
Research Site
Tyler, Texas, 75702
United States
Research Site
Salt Lake City, Utah, 84112
United States
Research Site
West Jordan, Utah, 84088
United States
Research Site
Fairfax, Virginia, 22031
United States
Research Site
Norfolk, Virginia, 23502
United States
Research Site
Richmond, Virginia, 23230
United States
Research Site
Spokane, Washington, 99204
United States
Research Site
Tacoma, Washington, 98405
United States
Research Site
Tacoma, Washington, 98415
United States

Collaborators and Investigators

Sponsor: AstraZeneca

  • Robert Haddad, MD, STUDY_CHAIR, Dana Farber Cancer Institute Massachusetts, USA
  • Lisa Licitra, MD, STUDY_CHAIR, Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan Milan, Italy

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-14
Study Completion Date2030-05-23

Study Record Updates

Study Start Date2023-12-14
Study Completion Date2030-05-23

Terms related to this study

Additional Relevant MeSH Terms

  • Locally Advanced Head and Neck Squamous Cell Carcinoma